Eisai/Biogen’s Leqembi Gets Some Medicare Coverage Certainty In CMS Update

The US Centers for Medicare and Medicaid Services (CMS) has answered a big question about Eisai Co., Ltd./Biogen, Inc.’s Leqembi (lecanemab) for early Alzheimer’s disease: Will the product garner Medicare coverage if its accelerated approval converts to full approval as expected by its 6 July action date with the US Food and Drug Administration? CMS said on 1 June that Medicare Part B will cover the costs of anti-amyloid antibodies on the same day that the FDA grants traditional approval, with one caveat.

While CMS said in its statement that it wants to make sure patients with mild cognitive impairment or early dementia caused by Alzheimer’s disease are able to access these medicines, the agency also noted Medicare Part B will cover the drugs “in appropriate settings that also support the collection of real-world information to study the usefulness of these drugs